H.R. 3686: Supporting Accessible, Flexible, and Effective Sunscreen Standards

This bill, known as the Supporting Accessible, Flexible, and Effective Sunscreen Standards Act (SAFE Sunscreen Standards Act), aims to amend the Federal Food, Drug, and Cosmetic Act to enhance the regulatory process for sunscreen active ingredients. The main focus is on safety, effectiveness, and the approval process for over-the-counter sunscreens.

Key Provisions of the Bill

1. Establishing Standards for Sunscreen Safety and Efficacy

The bill mandates that the Secretary of Health and Human Services establish standards for evaluating the safety and effectiveness of sunscreen active ingredients. These standards will:

• Ensure consumer safety through a thorough scientific evidence evaluation.
• Incorporate real-world evidence and observational studies to supplement traditional clinical tests for demonstrating safety and effectiveness.
• Set forth a clear pathway for marketing nonprescription sunscreen products deemed safe.

2. Non-Animal Testing Methods

The bill encourages the use of non-animal testing methods to assess the safety and efficacy of sunscreen ingredients. The Secretary will issue guidance within 180 days of enactment outlining acceptable nonclinical testing alternatives.

3. Administrative Order on Sunscreen Submissions

The final administrative order regarding sunscreen active ingredient submissions must:

• Account for historical data on the safety of ingredients already accepted in the U.S. market.
• Emphasize sunscreen as a vital prevention tool against skin cancer.
• Integrate the new standards established for sunscreen ingredients into the approval process.

4. Reporting and Transparency Obligations

The Secretary must provide annual reports to Congress outlining:

• The implementation status of the evidence and testing standards.
• The number of applications for sunscreen active ingredients reviewed with the new standards.
• Progress in utilizing nonclinical testing alternatives.

These reports will be made publicly available on the FDA's website within a few days of submission.

Context and Justifications

The bill is introduced against a backdrop of rising skin cancer rates in the United States, with findings highlighting that skin cancer is the most common cancer, with a significant number of diagnoses each year. It argues that many cases can be prevented through effective sun protection practices, such as the use of sunscreen.

Despite previous legislative efforts to speed up the approval of new sunscreen active ingredients, the FDA has not approved any new ingredients since 1999. The bill seeks to address this stagnation by improving the review process and encouraging innovation in sunscreen formulations.

Relevant Companies

• PG - Procter & Gamble: As a major manufacturer of skincare products, including sunscreens, any changes in regulatory requirements could impact their product development and marketing strategies.
• CLX - The Clorox Company: Known for personal care products that include sunscreens, this bill might influence their formulation processes and compliance standards.
• UN - Unilever: With a diverse portfolio in skincare, any alterations in regulatory standards could lead to changes in their sunscreen product lines and approval timelines.